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Article L5439-1 of the French Public Health Code

I. – Failure to comply with the conditions set out in article L. 5139-2 relating to the production, manufacture, transport, import and export, possession, supply, transfer, acquisition and use of micro-organisms and toxins included on the list provided for in article L. 5139-1 is punishable by five years’ imprisonment and a fine of €375,000. II. – The penalties referred to in the previous paragraph are increased to seven years’ imprisonment…

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Article L5439-3 of the French Public Health Code

For the criminal offences mentioned in this chapter, natural persons are also liable to the following additional penalties: 1° Display or dissemination of the decision handed down, under the conditions and subject to the penalties provided for in article 131-35 of the Criminal Code ; 2° Temporary or permanent disqualification from exercising one or more professions governed by this Code, from exercising a commercial or industrial profession, from directing, administering,…

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Article L5439-4 of the French Public Health Code

Legal entities declared criminally liable, under the conditions set out in article 121-2 of the French Criminal Code, for the offences set out in this chapter shall incur, in addition to the fine set out in article 131-38 of the same Code, the penalties set out in article 131-39, 2° to 9° of that Code.

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Article L5441-3 of the French Public Health Code

Failure by a sponsor, either within the two-month period preceding the clinical trial or when a substantial amendment to the trial is made, to send the Agency the information required by law relating to the testing of medicinal products is punishable by two years’ imprisonment and a fine of 30,000 euros. The same penalties will apply if a sponsor fails to comply with the Agency’s decision to oppose the implementation…

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Article L5441-4 of the French Public Health Code

The following are punishable by two years’ imprisonment and a fine of €150,000: 1° Failure by the holder of a manufacturing authorisation to have a qualified person in accordance with Article 97 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products; 2° Failure by the holder of a wholesale distribution authorisation to have a person responsible for wholesale distribution…

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Article L5441-5 of the French Public Health Code

Opening or operating an establishment defined in Article L. 5142-1, without the authorisation required pursuant to Articles 88 and 99 of Regulation (EU) 2019/6 of 11 December 2018 or without this having been renewed in the event of a change to the elements included in the initial authorisation, is punishable by two years’ imprisonment and a fine of €150,000.

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